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← See all Enteric Coated Stimulant Laxative brands

Enteric Coated Stimulant Laxative

Medically reviewed on April 18, 2017

Dosage form: tablet, delayed release
Ingredients: BISACODYL 5mg
Labeler: Lake Erie Medical DBA Quality Care Products LLC
NDC Code: 55700-512

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

Active ingredient (in each tablet)
Bisacodyl 5 mg

Purpose
Laxative

Uses
  • relieves occasional constipation
  • generally produces bowel movement in 6-12 hours

Warnings

Do not use
  • for longer than one week
  • when abdominal pain, nausea or vomiting are present
  • in children under 6 years of age
  • in persons who cannot swallow without chewing

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product
  • do not take dose within one hour of taking an antacid or milk
  • you may experience abdominal discomfort, faintness and cramps

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use of this product

These may indicate a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
DO NOT CHEW TABLETS
adults and children 12 years and over: 1-3 tablets once daily
children 6 to 11 years: 1 tablet once daily
children under 6 years: ask a doctor

Other information


store at 20°-25°C (68°-77°F)

Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

ENTERIC COATED STIMULANT LAXATIVE 
bisacodyl tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55700-512(NDC:0536-3381)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (DEACETYLBISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
CALCIUM SULFATE ANHYDROUS 
ANHYDROUS LACTOSE 
CARNAUBA WAX 
SILICON DIOXIDE 
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
GELATIN 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
POLYVINYL ACETATE PHTHALATE 
POVIDONE 
SHELLAC 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeTCL;003
Contains    
Packaging
#Item CodePackage Description
1NDC:55700-512-3030 TABLET, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/22/2011
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIOperations
Lake Erie Medical DBA Quality Care Products LLC831276758repack(55700-512)

 
Lake Erie Medical DBA Quality Care Products LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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